ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization, proud to foster an inclusive environment that drives innovation and excellence.
We are currently seeking a Quality Assurance Specialist to join our diverse and dynamic team. This role is responsible for supporting quality compliance across ICON’s clinical programmes, with a particular focus on externally manufactured Clinical Trial Materials (CTM), including Finished Drug Product, clinical packaging, and labeling.
This role is accountable for batch disposition for Clinical Trials Materials manufactured at CMOs.
What You Will Do
- Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs.
- Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required).
- Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling.
- Support batch disposition processes in accordance with established quality procedures and regulatory requirements.
- Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply.
- Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections.
- Identify, assess, and escalate product-related quality and regulatory issues and emerging trends.
- Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply.
Your Profile
- Bachelor’s degree in a related field.
- At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry.
- Working knowledge of cGMP regulations.
- Experience reviewing manufacturing or clinical documentation.
What ICON Can Offer You
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers a comprehensive range of benefits designed to support well‑being, work‑life balance, and long‑term career growth. Benefits are competitive within each country and tailored to support you and your family.
Our benefits may include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning options to help you save and plan with confidence for the future
- Global Employee Assistance Programme (TELUS Health), providing 24‑hour access to a worldwide network of over 80,000 independent, specialised professionals supporting you and your family’s well‑being
- Life assurance
- Flexible, country‑specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, and more
Visit our careers site to learn more about the benefits ICON offers.
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates and are committed to maintaining a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you require a reasonable accommodation due to a medical condition or disability at any stage of the application process, or in order to perform the essential functions of the role, please let us know or submit a request.
Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply—there’s every chance you’re exactly what we’re looking for, whether for this role or other opportunities at ICON.
If you are a current ICON employee, please apply through the internal careers portal.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Skills Required
- Bachelor's degree in a related field
- At least 3 years of relevant QA compliance and/or Quality Product Disposition experience
- Working knowledge of cGMP regulations
- Experience reviewing manufacturing or clinical documentation
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
-
Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
-
Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
-
Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
